Sterile port connection

ABSTRACT

Embodiments of the present disclosure are directed to connection assemblies providing a connection between a tubing a port. The port can be disposed within and particularly extending through a bore of the port. The port and tube are coupled to provide an aseptic connection.

CROSS-REFERENCE TO RELATED APPLICATION(S)

This application is a divisional and claims priority under 35 U.S.C. §120 to U.S. patent application Ser. No. 15/085,549 entitled, “STERILEPORT CONNECTION ,” by Michael R. Huschke, filed Mar. 30, 2016, whichapplication claims priority under 35 U.S.C. § 119(e) to U.S. ProvisionalApplication No. 62/149,162 entitled, “STERILE PORT CONNECTION,” byMichael R. Huschke, filed Apr. 17, 2015, of which all are assigned tothe current assignee hereof and incorporated herein by reference intheir entireties.

FIELD OF THE DISCLOSURE

The present disclosure relates to sterile connections, and moreparticularly to, sterile connections between a tubing and a port.

RELATED ART

The state of the art includes a variety of style of port connections,but all have drawbacks. For example, state of the art port connectionsin isolation bags require a double sided port and a first tubing coupledto the port outside of the bag and a separate tubing coupled to the portinside the bag. This double connection is time consuming and expensiveto produce and provides unnecessary points of failure.

The present inventors have created a unique port connection assembly andmethods of forming a sterile connection that overcomes these and otherdrawbacks. For example, embodiments of the present disclosure provide asingle port aseptic connection where the bore of the port does not forma fluid facing surface.

BRIEF DESCRIPTION OF THE DRAWINGS

Embodiments are illustrated by way of example and are not limited in theaccompanying figures.

FIG. 1 illustrates an exploded perspective view of a connection assemblyaccording to one embodiment.

FIG. 2 illustrates a cross-section view of the assembled connectionassembly of FIG. 1.

FIG. 3 illustrates an exploded perspective view of a connection assemblycontaining a compressive element according to another embodiment.

FIG. 4 illustrates a cross section view of the assembled connectionassembly of FIG. 3.

FIG. 5 illustrates a cross-section view of a connection assemblyaccording to another embodiment.

FIG. 6 illustrates a perspective view of a connection assembly coupledto a vessel according to one embodiment.

FIG. 7 illustrates a close-up view of callout A of FIG. 6.

Skilled artisans appreciate that elements in the figures are illustratedfor simplicity and clarity and have not necessarily been drawn to scale.For example, the dimensions of some of the elements in the figures maybe exaggerated relative to other elements to help to improveunderstanding of embodiments of the invention.

DETAILED DESCRIPTION

The following description in combination with the figures is provided toassist in understanding the teachings disclosed herein. The followingdiscussion will focus on specific implementations and embodiments of theteachings. This focus is provided to assist in describing the teachingsand should not be interpreted as a limitation on the scope orapplicability of the teachings. However, other embodiments can be usedbased on the teachings as disclosed in this application.

As used herein, the phrase “engagement element” refers to a featuredisposed on an outer surface or on an inner diameter of the port, suchas in bore of the port, that is adapted to engage with a separateelement from the port. An engagement element can include protrusions,such as a barb, depressions, recesses, or any other structure that isadapted to engage with a separate element from the port when making asterile connection.

As used herein, a “vessel” refers to any structure capable of receivingand a holding a fluid, which could include liquids, gases, orcombinations thereof. A vessel includes, but is not limited to an openvessel, a closed vessel, a rigid vessel, a flexible vessel, atransparent vessel, a bag such as a mixing bag or an isolation bag, adrum, a container, a room, or any other structure to which a sterileconnection is desired.

The terms “comprises,” “comprising,” “includes,” “including,” “has,”“having” or any other variation thereof, are intended to cover anon-exclusive inclusion. For example, a method, article, or apparatusthat comprises a list of features is not necessarily limited only tothose features but may include other features not expressly listed orinherent to such method, article, or apparatus. Further, unlessexpressly stated to the contrary, “or” refers to an inclusive-or and notto an exclusive-or. For example, a condition A or B is satisfied by anyone of the following: A is true (or present) and B is false (or notpresent), A is false (or not present) and B is true (or present), andboth A and B are true (or present).

Also, the use of “a” or “an” is employed to describe elements andcomponents described herein. This is done merely for convenience and togive a general sense of the scope of the invention. This descriptionshould be read to include one, at least one, or the singular as alsoincluding the plural, or vice versa, unless it is clear that it is meantotherwise. For example, when a single item is described herein, morethan one item may be used in place of a single item. Similarly, wheremore than one item is described herein, a single item may be substitutedfor that more than one item.

Unless otherwise defined, all technical and scientific terms used hereinhave the same meaning as commonly understood by one of ordinary skill inthe art to which this invention belongs. The materials, methods, andexamples are illustrative only and not intended to be limiting. To theextent not described herein, many details regarding specific materialsand processing acts are conventional and may be found in textbooks andother sources within the fluid transfer arts.

The present disclosure is directed to sterile seamless port connections.The concepts are better understood in view of the embodiments describedbelow that illustrate and do not limit the scope of the presentinvention.

Referring now to FIGS. 1 and 2, one embodiment of a sterile connection10 includes a port 20 having a bore 22 defining a passageway; and a tube30 disposed within the bore 22 of the port 20. An overmolded element 40couples the tube 30 to the port 20.

As illustrated in FIGS. 1 and 2, in particular embodiments, the port 20can include one or more engagement elements 24 disposed on the outersurface of the port 20. For example, the one or more engagement elements24 can include protrusions such as barbs, depressions, recesses, or anycombination thereof. In very particular embodiments, the one or moreengagement elements 24 can include one or more barbs.

As illustrated in FIG. 1, the one or more engagement elements 24 can becontinuously disposed about the outer circumference of the port 20. Inother embodiments, the one or more engagement elements can bediscontinuously disposed about the outer circumference of the port.

In certain embodiments, the one or more engagement elements 24 caninclude at least 2 or even at least 3 distinct engagement elements 24.

Referring again to FIGS. 1 and 2, the port 20 can include a bore 22 thatdefines a passageway through the port 20. The bore 22 has a diameterB_(D) and has a length B_(L) extending axially from the distal end 23 ofthe bore 22 to the proximal end 25 of the bore 22.

In particular embodiments, the diameter B_(D) of the bore 22 can begenerally consistent through the length B_(L) of the bore 22. In otherembodiments, the bore 22 can include a taper, such as a taper from thedistal end 23 to the proximal end 25. In still further embodiments, thebore can include a taper from the proximal end 25 to the distal end 23.

In certain embodiments, the tube 30 can extend entirely through the bore22, such that the bore 22 does not form a fluid facing surface in aformed connection. In other embodiments, the tube 30 can extendpartially within the bore.

In certain embodiments, after insertion of the tube 30 through the bore22, a fitting 50 (see FIG. 6) can be attached to the tube 30. Forexample, a fitting 50 can include a sampling device, such as a syringe;a connector, such as a tee, a wye, a cross; or a valve or any otherstructure to which it may be advantages to couple the end of the tube.

For example, as illustrated in FIG. 6, the tube 30 can be coupled to asampling device fitting 50, such as a syringe after insertion of thetube 30 through the bore 22 of the port 20.

Referring again to FIG. 2, the tube 30 can have an outside diameterT_(OD) that is generally the same as or less than the diameter of thebore. In fact, a particular advantage of certain embodiments of thepresent disclosure is the ability to use multiple tube sizes with asingle port and still obtain an aseptic connection. For example, sincethe overmolded element is formed directly on the tube and port afterinsertion of the tube through the bore, any tube having an outerdiameter that is generally equal to or less than the bore diameter canbe aseptically connected.

Accordingly, in certain embodiments, the tube 30 can directly contactthe surface of the bore 22. In other embodiments, the outer profile ofthe tube 30 can be spaced apart from the surface of the bore 22. Instill further embodiments, the outer profile of the tube can becomplementary to the profile of the bore, as viewed in thecross-section.

In certain embodiments, the inside profile of the tube and/or the borecan have a generally concentric profile.

Referring to FIGS. 1 to 4, the sterile connection 10 can include anovermolded element 40 coupling the tube 30 and port 20. The overmoldedelement 40 can be formed after insertion of the tube 30 within the bore22 of the port 20. Overmolding can allow for a complimentary profile andintimate contact with the port 20 and the tube 30. Accordingly, inparticular embodiments, the overmolded element 40 can be in intimate anddirect contact with the outer surface of the tube 30 and the outersurface of the port 20.

In particular embodiments, the overmolded element 40 can be disposedabout the one or more engagement elements 24 disposed on the outersurface of the port 20. As described above, the overmolded element 40can be in intimate contact with at least one of the one more engagementelements 24. In particular embodiments, the overmolded element 40 can bein intimate contact with at least two engagement elements 24.

The materials composing the tube 30, port 20, and overmolded element 40can be selected depending on the particular application and according tovarious embodiments of the present disclosure.

In certain embodiments, the port 20 can be composed of a thermoplasticbased material. For example, the port 20 can be composed of apolypropylene (PP) based material, a polyethylene (PE) based material,such as a high density polyethylene (HDPE) based material or a lowdensity polyethylene (LDPE), a fluoropolymer based material, such as PFAor PVDF, a polyamide based material, such as Nylon; or any combinationthereof. In particular embodiments, the port 20 can be composed of apolypropylene (PP) based material, a polyethylene (PE) based material,such as a high density polyethylene (HDPE) based material or a lowdensity polyethylene (LDPE), or combinations thereof.

A particular advantage of certain embodiments of the present disclosureis a wide diversity of possible materials for formation of the port. Forexample, as described above, certain embodiments of the sterileconnection include the tube extending entirely through the bore of theport such that the port does not form a fluid facing surface. In suchembodiments, since the port is non-fluid facing, the materials composingthe port do not have to satisfy the stringent requirements of fluidcontacting surface, particularly in the biopharmaceutical field thatinvolves very sensitive fluids.

In further embodiments, the tube 30 can be composed of a thermoset basedmaterial. For example, the tube 30 can be composed of a silicone basedmaterial.

In certain embodiments, the tube 30 can be composed of a thermoplasticmaterial. For example, in particular embodiments, the tube can becomposed of a thermoplastic elastomer (TPE) based material, such asC-Flex®.

In certain embodiments, the overmolded element 40 can be composed of athermoplastic based material. For example, the overmolded element 40 canbe composed of a polypropylene (PP) based material, a polyvinyl (PV)based material, such as polyvinyl chloride (PVC) based material, aelastomeric based material, or any combination thereof.

In further embodiments, the overmolded element 40 can be composed of athermoset based material. For example, the overmolded can be composed ofa silicone 40 based material.

The particular selection of materials composing the tubing 30, port 20,and overmolded element 40 achieve different embodiments of the presentdisclosure. It is to be understood that any combination of materials forthe tube, port, and overmolded elements described above are within thescope of certain embodiments of the present disclosure.

In particular embodiments, the tubing 30, port 20, and overmoldedelement 40 can be composed of a material that allows for covalentbonding between one or both of the tubing and the port to the overmoldedelement.

In other embodiments, such as when covalent bonding between the one orboth of the tubing 40 and the port 20 to the overmolded element is notpossible, the sterile connection can further include a compressiveelement 60 as illustrated in FIGS. 3 and 4. The compressive element 60can serve to provide a compressive force radially inwardly to secure theovermolded element about the port. For example, the compressive element50 can be disposed over the port and the overmolded element about atleast one of the one more engagement elements. A compressive element caninclude, for example, a clamp such as a Barblock® (available fromSaint-Gobain Performance Plastics Corporation), a band, a zip-tie or anyother structure adapted to provide a compressive force radiallyinwardly. Examples of suitable clamps can include those described inU.S. patent application Ser. No. 12/437,260, U.S. Pat. Nos. 7,922,213,7,922,212, and U.S. patent application Ser. No. 10/963,457.

Referring now to FIG. 5, one embodiment of a sterile connection 10 caninclude a first tube 30 disposed within the bore 22 of the port 20, asecond tube 35 disposed over the first tube 30 and disposed over theport 20; an overmolded element 40 coupling the first tube 30 and thesecond tube 35 at a distal end 36 and a compressive element 60 disposedabout the second tube 35 and the port 20. As illustrated in FIG. 5, theport 20 can include an engagement element 24, such as a barb, and thecompressive element 40 can be disposed about the engagement element 24and the second tube 35. Accordingly, the first and second tubes 30,35are sealed together at the distal end 36 of the second tube 35 via theovermolded element 40, and the second tube 35 and the port 20 are sealedtogether by the compressive element 60 at the proximal end 37 of thesecond tube 35.

Referring to FIGS. 6 and 7, another aspect of the present disclosure isdirected to an assembly including any embodiment of the sterileconnection 10 described herein and a vessel 70 having an interior cavity72. The port 20 can be coupled to the vessel 70 and the bore 22 of theport 20 can be in fluid communication with the interior cavity 72 of thevessel 70. The tubing 30 can extend from outside of the vessel 70,through the port 20, and into the interior cavity 72 of the vessel 70.The tubing can the be sealed to the port as described in any of theembodiments provided above, such as, for example overmolding anovermolded element over the port and the tubing and optionally providinga compressive element.

In certain embodiments, the vessel 70 can include a flexible vessel thatis coupled to the port 20. A flexible vessel refers to a vessel havingat least one flexible sidewall.

In other embodiments, the vessel 70 can include a rigid vessel that iscoupled to the port.

In still further embodiments, the assembly can include a flexible vessel70 that is coupled to the port 20 and a rigid vessel (not shown) tosupport the flexible vessel 70 and including a structure that canaccommodate the port 20 coupled to the flexible vessel 70. For example,the rigid vessel can include an aperture having a size large enough forthe port to protrude through a wall of the rigid vessel.

As described above, in particular embodiments, the tubing 30 can extendentirely through the bore 22 of the port 20, and therefore open into theinner cavity 72 of the vessel 70. Accordingly, the bore 22 of the port20 can be non-fluid facing.

The port 20 can be coupled to the vessel 70 by any desirable method. Forexample, in particular embodiments, the port 20 can be adhered, bonded,welded, or otherwise secured to the vessel 70. As a particular exampleand referring again to FIG. 7, the port 20 can include a flange 27extending radially from the bore 22. The flange 27 can be welded to theinner or outer surface of the vessel. In particular embodiments, a holeis made in the vessel, and the port 20 is inserted through the hole suchthat the flange 27 contacts the inner surface 77 of the vessel 70 and iscoupled thereto.

In very particular embodiments, the vessel 70 can be an isolationvessel, such as an isolation bag. An isolation vessel does not involvethe direct fluid contact with the vessel, but rather provides anisolated environment to protect sensitive fluids. The interior cavity ofthe isolation bag must remain aseptic during use. Isolation bags aretypically used in the pharmaceutical industry, such as to sample a givenfluid and can include user manipulation ports such that a user canmanipulate contents within the isolation bag without breaking theaseptic nature of the interior cavity. Traditional methods to connect asampling device, such as a syringe port that is fluid communication witha structure outside of the isolation bag, included incorporating adouble sided port, and making two connections, one wholly outside of theisolation bag, and one wholly inside the isolation bag. Accordingly,certain embodiments of the present disclosure as described above allowfor the use of a singe port, with one connection where the tubingextends from outside of the isolation bag all the way through the port.The end of the tubing can then be connected to a fitting, such as asampling device.

Many different aspects and embodiments are possible. Some of thoseaspects and embodiments are described below. After reading thisspecification, skilled artisans will appreciate that those aspects andembodiments are only illustrative and do not limit the scope of thepresent invention. Embodiments may be in accordance with any one or moreof the items as listed below.

Item 1. An assembly comprising:

-   -   a. a port comprising a bore defining a passageway;    -   b. a tube disposed through the bore; and    -   c. an overmolded element coupling the tube to the port;    -   d. wherein the bore is non-fluid facing.

Item 2. An assembly comprising:

-   -   a. a port comprising a bore defining a passageway;    -   b. a first tube disposed through the bore; and    -   c. a second tube disposed over the first tube and disposed over        the port;    -   d. an overmolded element coupling the first tube to the second        tube; and    -   e. a compressive element disposed over the second tube and the        port.

Item 3. An assembly comprising:

-   -   a. a vessel having an interior cavity;    -   b. a port having a bore defining a passageway into the interior        cavity of the vessel; and    -   c. a tube;    -   d. wherein the tube is coupled to the port;    -   e. wherein the tube extends into the inner cavity of the vessel;        and    -   f. wherein the port is non-fluid facing.

Item 4. An assembly comprising:

-   -   a. an isolation vessel having an interior cavity;    -   b. a port coupled to the isolation vessel, wherein the port        comprises a bore defining a passageway to the interior cavity of        the vessel; and    -   c. a tube extending through the bore and coupled to the port,        wherein the coupling between the port and the tubing is aseptic.

Item 5. An assembly comprising:

-   -   a. a port having a bore defining a passageway, the bore having        an inner diameter;    -   b. a tube extending through the bore, the tube having an outer        diameter, wherein the outer diameter of the tube is less than        the inner diameter of the bore;    -   c. an overmolded element disposed over and coupling the tube and        port.

Item 6. An assembly comprising:

-   -   a. a first component having a bore defining a passageway;    -   b. a second component having a bore defining a passageway and        comprising at least one engagement element disposed on an outer        surface of the second component, wherein the inner diameter of        the second component is generally equal to or greater than the        outside diameter of the first component, wherein the first        component is disposed within the bore of the second component,        and an overmolded element coupling the first component to the        second component.

Item 7. The assembly of item 6, wherein the first component comprises atube; and wherein the second component comprises a port.

Item 8. A method of making a connection between a tubing and a port, themethod comprising:

-   -   a. providing a port comprising a bore defining a passageway and        one or more engagement elements disposed about an outer        periphery of the port;    -   b. inserting a tube through bore of the port; and    -   c. overmolding an element about the engagement elements and the        tube.

Item 9. A method of making a connection between a tubing and a port, themethod comprising:

-   -   a. providing a port comprising a bore defining a passageway and        one or more engagement elements disposed about an outer        periphery of the port;    -   b. inserting a first tube through bore of the port;    -   c. disposing a second tube over the first tube and about one or        more of the engagement elements on the port; and    -   d. overmolding an element to couple the first tube to the second        tube; and    -   e. providing a compressive element to provide radial compression        of the second tube about the one or more engagement elements of        the port.

Item 10. The assembly or method of any one of the preceding items,wherein the port further includes one or more engagement elementsdisposed about an outer periphery of the port; the tube is composed of asilicone based material; and the overmolded element is composed of asilicone based material; and wherein the assembly further comprises aretention element disposed about and retaining the overmolded elementabout the port.

Item 11. The assembly or method of any one of the preceding items,wherein the port further includes one or more engagement elementsdisposed about an outer periphery of the port; the tube is composed of athermoplastic based material; and the overmolded element is composed ofa thermoplastic based material; wherein the overmolded element iscovalently bonded to the tube.

Item 12. The assembly or method of any one of the preceding items,wherein the bore of the port is non-fluid facing.

Item 13. The assembly or method of any one of the preceding items,wherein the port is non-fluid facing.

Item 14. The assembly or method of any one of the preceding items,wherein the port is entirely non-fluid facing.

Item 15. The assembly or method of any one of the preceding items,wherein the port further includes one or more engagement elementsdisposed about an outer periphery of the port.

Item 16. The assembly or method of any one of the preceding items,wherein the one or more engagement elements comprise a barb.

Item 17. The assembly or method of any one of the preceding items,wherein the port does not form a fluid contacting surface.

Item 18. The assembly or method of any one of the preceding items,wherein the port is composed of a thermoplastic based material.

Item 19. The assembly or method of any one of the preceding items,wherein the port is composed of a polypropylene (PP) based material, apolyethylene based material, such as a high density polyethylene (HDPE)based material or a low density polyethylene (LDPE), a fluoropolymerbased material, such as PFA or PVDF, a polyamide based material, such asNylon; or any combination thereof.

Item 20. The assembly or method of any one of the preceding items,wherein the port is composed of a polypropylene (PP) based material,high density polyethylene (HDPE) based material, a low densitypolyethylene (LDPE), a fluoropolymer based material or combinationsthereof.

Item 21. The assembly or method of any one of the preceding items,wherein the assembly or method further comprises a vessel having aninterior cavity, wherein the port is disposed on the vessel, and whereinthe bore defines a passageway into the interior cavity of the vessel.

Item 22. The assembly or method of any one of the preceding items,wherein the vessel comprises at least one flexible wall.

Item 23. The assembly or method of any one of the preceding items,wherein the vessel comprises a flexible bag.

Item 24. The assembly or method of any one of the preceding items,further comprising a rigid vessel and a flexible vessel.

Item 25. The assembly or method of any one of the preceding items,wherein the vessel comprises an isolation bag.

Item 26. The assembly or method of any one of the preceding items,wherein the overmolded element is composed of a thermoplastic basedmaterial.

Item 27. The assembly or method of any one of the preceding items,wherein the overmolded element is composed of a thermoplastic elastomerbased material.

Item 28. The assembly or method of any one of the preceding items,wherein the overmolded element is composed of a silicone based material.

Item 29. The assembly or method of any one of the preceding items,wherein the overmolded element is composed of a polypropylene basedmaterial, a polyvinyl based material, such as polyvinyl chloride (PVC)based material, a thermoplastic elastomeric based material, or anycombination thereof.

Item 30. The assembly or method of any one of the preceding items,wherein the tube is composed of a thermoplastic based material.

Item 31. The assembly or method of any one of the preceding items,wherein the tube is composed of a thermoplastic elastomer basedmaterial.

Item 32. The assembly or method of any one of the preceding items,wherein the tube is composed of a silicone based material.

Item 33. The assembly or method of any one of the preceding items,wherein the compressive element applies a compressive force to squeezethe overmolded element or second tube about at least one of the one ormore engagement elements.

Item 34. The assembly or method of any one of the preceding items,wherein the compressive element comprises a clamp such as a barblock, aband, or a zip-tie.

Item 35. The assembly or method of any one of the preceding items,wherein the compressive element comprises a barblock.

Item 36. The assembly or method of any one of the preceding items,wherein the outside diameter of the tube is generally the same as orless than the inner diameter of the bore.

Item 37. The assembly or method of any one of the preceding items,wherein the outside diameter of the tube is generally the same as theinner diameter of the bore.

Item 38. The assembly or method of any one of the preceding items,wherein the tubing extends entirely through the port.

Item 39. The assembly or method of any one of the preceding items,wherein the tubing extends entirely through the port and opens into theinner cavity of the vessel.

Item 40. The assembly or method of any one of the preceding items,wherein the outer surface of the tube directly contacts the innersurface of the bore.

Item 41. The assembly or method of any one of the preceding items,wherein the outer surface of the tube is spaced apart from the innersurface of the bore.

Item 42. The assembly or method of any one of the preceding items,wherein the outer profile of the tube is complementary to an innerprofile of the bore as viewed in the cross-section.

Item 43. The assembly or method of any one of the preceding items,wherein the outer profile of the tube and the inner profile of the boreare generally circular as viewed in the cross-section.

Item 44. The assembly or method of any one of the preceding items,wherein the port is coupled to a wall of the vessel.

Item 45. The assembly or method of any one of the preceding items,wherein the port is coupled to a flexible wall of the vessel.

Item 46. The assembly or method of any one of the preceding items,wherein the port is coupled to an interior surface of the vessel.

Item 47. The assembly or method of any one of the preceding items,wherein the assembly further comprises a fitting disposed on the end ofthe tubing.

Item 48. The assembly or method of any one of the preceding items,wherein the fitting comprises a sampling device.

Item 49. The assembly or method of any one of the preceding items,wherein the fitting comprises a syringe.

Note that not all of the activities described above in the generaldescription or the examples are required, that a portion of a specificactivity may not be required, and that one or more further activitiesmay be performed in addition to those described. Still further, theorder in which activities are listed is not necessarily the order inwhich they are performed.

Benefits, other advantages, and solutions to problems have beendescribed above with regard to specific embodiments. However, thebenefits, advantages, solutions to problems, and any feature(s) that maycause any benefit, advantage, or solution to occur or become morepronounced are not to be construed as a critical, required, or essentialfeature of any or all the claims.

The specification and illustrations of the embodiments described hereinare intended to provide a general understanding of the structure of thevarious embodiments. The specification and illustrations are notintended to serve as an exhaustive and comprehensive description of allof the elements and features of apparatus and systems that use thestructures or methods described herein. Separate embodiments may also beprovided in combination in a single embodiment, and conversely, variousfeatures that are, for brevity, described in the context of a singleembodiment, may also be provided separately or in any subcombination.Further, reference to values stated in ranges includes each and everyvalue within that range. Many other embodiments may be apparent toskilled artisans only after reading this specification. Otherembodiments may be used and derived from the disclosure, such that astructural substitution, logical substitution, or another change may bemade without departing from the scope of the disclosure. Accordingly,the disclosure is to be regarded as illustrative rather thanrestrictive.

What is claimed is:
 1. An assembly comprising: a. an isolation vesselhaving an interior cavity; b. a port coupled to the isolation vessel,wherein the port comprises a bore defining a passageway to the interiorcavity of the vessel; and c. a tube extending through the bore andcoupled to the port, wherein the coupling between the port and thetubing is aseptic.
 2. An assembly comprising: a. a port having a boredefining a passageway, the bore having an inner diameter; b. a tubeextending through the bore, the tube having an outer diameter, whereinthe outer diameter of the tube is less than the inner diameter of thebore; c. an overmolded element disposed over and coupling the tube andport.
 3. An assembly comprising: a. a first component having a boredefining a passageway; b. a second component having a bore defining apassageway and comprising at least one engagement element disposed on anouter surface of the second component, wherein the inner diameter of thesecond component is generally equal to or greater than the outsidediameter of the first component, wherein the first component is disposedwithin the bore of the second component, and an overmolded elementcoupling the first component to the second component.
 4. The assembly ofclaim 3, wherein the first component comprises a tube; and wherein thesecond component comprises a port.
 5. The assembly of claim 1, whereinthe bore of the port is non-fluid facing.
 6. The assembly of claim 1,wherein the port is non-fluid facing.
 7. The assembly of claim 1,wherein the port is entirely non-fluid facing.
 8. The assembly of claim2, wherein the port further includes one or more engagement elementsdisposed about an outer periphery of the port
 9. The assembly of claim1, wherein the port does not form a fluid contacting surface.
 10. Theassembly of claim 2, wherein the assembly further comprises a vesselhaving an interior cavity, wherein the port is disposed on the vessel,and wherein the bore defines a passageway into the interior cavity ofthe vessel.
 11. The assembly of claim 10, wherein the vessel comprisesat least one flexible wall.
 12. The assembly of claim 3, furthercomprising a rigid vessel and a flexible vessel.
 13. The assembly ofclaim 2, wherein the overmolded element is composed of a thermoplasticbased material.
 14. The assembly of claim 2, wherein the overmoldedelement is composed of a silicone based material.
 15. The assembly ofclaim 2, wherein the overmolded element is composed of a polypropylenebased material, a polyvinyl based material, such as polyvinyl chloride(PVC) based material, a thermoplastic elastomeric based material, or anycombination thereof.
 16. The assembly of claim 1, wherein the outsidediameter of the tube is generally the same as the inner diameter of thebore.
 17. The assembly of claim 1, wherein the tube extends entirelythrough the port.
 18. The assembly of claim 1, wherein the tube extendsentirely through the port and opens into the inner cavity of the vessel.19. The assembly of claim 1, wherein the assembly further comprises afitting disposed on the end of the tubing.
 20. The assembly of claim 19,wherein the fitting comprises a syringe.